MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number	REACT-71
Medical Device Problem Codes	Collapse (1099); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a dsa and intracranial thrombectomy procedure, the react-71 catheter was rough and collapsed after multiple attempts to retrieve and enter the long sheath.The procedure involved accessing the internal carotid artery, which had a diameter of 4.2 millimeters and moderate vessel tortuosity.The catheter was prepared and flushed as indicated in the instructions for use.No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that the react catheter was replaced with a 6f intermediate catheter from achieva and swam again to complete the surgery.Regarding the cause, the customer reported that there was resistance when the long sheath was inserted again after a suction.It collapsed after repeated insertion.The specific reason was unknown.Patient's baseline: tici level 1, nihss 9 points.Patient¿s post-thrombectomy¿condition: tici level 3, nihss 1 point.
Additional Manufacturer Narrative
H3: product analysis of react-71, lotno: b737709.As found condition: the react-71 catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an opened react-71 inner pouch.Damage location details: no damage was found with the react-71 catheter hub.However, dried blood was found within the catheter hub.The distal ~18.0cm of the react-71 catheter body was found stretched.The react-71 catheter distal marker/tip was found damaged.Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance¿ report could not be confirmed.However, the customer¿s ¿catheter damage¿ report was confirmed.The react-71 catheter body was found stretched with the distal marker/tip damaged.Possible causes of ¿marker band damage¿ include patient vessel tortuosity, advancing or retrieving the device against resistance, or vessel calcification or stenosis.Possible causes of ¿catheter stretch¿ include patient vessel tortuosity, catheter entrapment, incompatible devices, advancing or retrieving the device against resistance, or excessive force used in the procedure (pushing and pulling).However, the cause of the catheter damage could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: REACT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21536864
• Report Number: 2029214-2025-00571
• Device Sequence Number: 18155282
• Product Code: DQY
• UDI-Device Identifier: 00847536044197
• UDI-Public: 00847536044197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K182097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B737709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 04/22/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female